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Inside FDA Compliance

A community for medical device, pharma and other FDA-regulated industries.

News

  • Current Good Manufacturing Practices Conference by ISPE, 03/15/2012
  • FDA Issues Draft Guidance on Biosimilar Product Development by FDA, 02/13/2012
  • FDA and Industry Reach Agreement in Principle on Medical Device User Fees by FDA, 02/06/2012
  • Two Days of ISO 14971 Training by FDAnews, 01/06/2012
  • 2011 Guide to Medical Device Regulations Released by FDAnews, 11/28/2011
  • ‘CAPA Is King’ Virtual Conference by FDAnews, 11/15/2011
  • Optical Reflectors: The Alternative to Rigid Measurement Setups by Daniel Brown, 11/08/2011
  • Fourth Annual Risk Management and Drug Safety Summit by FDAnews, 10/18/2011
  • Quality System Inspection Technique (QSIT) Course Available by Oriel STAT A MATRIX, 08/30/2011
  • New Pharmaceutical Quality Management Systems Auditor Certification Scheme by International Register of Certificated Auditors, 08/30/2011

Past News

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Articles & Columns

Articles

  • FDA and EU Spar on Medical Device Regulation by Michael Causey, 05/01/2012
  • FDA Introduces Triage Pilot Program by Alberto Gutierrez, 04/25/2012
  • Medical Device CEO Laments ‘Anti-Industry’ FDA Culture by Michael Causey, 04/18/2012
  • Going Long in Medical Device Manufacturing by Banner Medical, 03/29/2012
  • Lawmakers’ Silly Season No Laughing Matter for Device Industry by Michael Causey, 03/28/2012
  • FDA Budget Could Hike User Fees, Overseas Inspections by Michael Causey, 03/13/2012
  • FDA Offers Salty Recipe for Increased Food Regulation by Michael Causey, 01/06/2012
  • Quality Pro Salaries Keep Pace with Inflation by American Society for Quality ASQ, 12/07/2011
  • FDA Reorganization Signals More Inspections for Drug, Device Firms by Michael Causey, 10/07/2011
  • Foreign Exporters Study U.S. Food Safety Law by FDA, 10/03/2011

Past Articles

Columns

  • Julie Gunlock January 25, 2012 Misguided FDA Food Regulations Will Hike Costs, Not Safety
  • Les Schnoll August 30, 2011 The Food Safety Modernization Act: A Public Health Imperative
  • Cathy Crawford August 22, 2011 When ‘Reason to Believe’ Halts Food Production
  • Patrick Stone August 10, 2011 FDA Protects Us from Terror of Unpasteurized Milk

Past Columns

Quality Information

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